(262 days)
The AbbVie NJ is intended to provide short-term enteral access for administration of medication to the small intestine.
The AbbVie™ NJ is a 10 FR, 152 cm, naso-jejunal (NJ) tube made of white radiopaque polyurethane. The distal coiled end region and bolus tip are coated with a water activated lubricant. The AbbVie NJ includes a silicone coated Stylet.
This document describes the pre-market notification for the AbbVie™ NJ device, a naso-jejunal tube. It explicitly states that "No clinical evaluations were performed or relied upon for the determination of substantial equivalence." This means that the device's performance was assessed through non-clinical data and comparison to a predicate device, rather than through a clinical study that would generate the kind of data you're asking for regarding acceptance criteria, sample sizes, and expert review.
Therefore, I cannot provide the requested information, including a table of acceptance criteria and reported device performance based on a human study, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or details about training sets.
The relevant information from the document is as follows:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical):
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Biocompatibility: Conformance to ISO 10993-1:2009 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process. | The material composition of the AbbVie NJ shows acceptable performance across all biocompatibility protocols tested per ISO 10993-1:2009. |
| Enteral Feeding Catheters and Giving Sets: Conformance to BS EN 1615:2000 Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing. | An assessment of the AbbVie NJ has been completed and shown to be acceptable per BS EN 1615:2000. |
| Small-bore Connectors: Conformance to ISO 80369-1:2010 Small-bore Connectors for Liquids and Gases in Healthcare Applications- Part 1: General requirements. | An assessment of the AbbVie NJ has been completed and shown to be acceptable per ISO 80369-1:2010. |
| Substantial Equivalence to Predicate Device (Entriflex™ Feeding Tube, K833621): No differences that would affect safety or effectiveness, and no new issues of safety or effectiveness are raised. | The AbbVie NJ is substantially equivalent to the currently marketed predicate device, Entriflex Feeding Tube (K833621). Both devices are naso-enteric tubes with the same fundamental structure and function. The AbbVie NJ tube diameter (10 FR) falls within the predicate's range. Duration of use (30 days or less), stylet feature, tube material (polyurethane), and anatomical delivery are the same. Differences (tube length, distal end, proximal connector, sterility) do not raise new issues of safety or effectiveness. The indication for use (administration of medication) is within the predicate's indications. |
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (tube), not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device (tube).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical studies, conformance to established industry standards and substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set: Not applicable. No clinical training set.
9. How the ground truth for the training set was established: Not applicable. No clinical training set.
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.